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Study never started. PI left institution.
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The investigator's goal is to determine the effectiveness of stromal vascular fraction (SVF) cell injection to treat small rotator cuff tears without surgery.
Small rotator cuff tendon tears are a hard task in shoulder care. They are often not operated on because research has not shown any increased benefit of surgery over physical therapy. The most common way to treat these tears is through physical therapy or steroid injections. However, the relief doesn't last very long. Recent studies have shown a lot of tears get worse over time. This happens because the physical therapy options can treat the pain and symptoms, but do not heal the actual tear.
Another non-surgical option for treating small tears is through adipose-derived stem cells. Adipose-derived stem cells are cells that are found in the fat in our bodies. The cells have shown promise in fixing tissues and may provide help to treat small rotator cuff tears. The investigators are studying a part of these fat cells known as the stromal vascular fraction (SVF). The SVF contains a number of cells that are able to become a variety of different cells. This is important because they may be able to turn into cells that may help heal the damaged rotator cuff tendons. These cells have been shown to improve results after rotator cuff surgery, but no research has used these cells to help small tears without surgery. The use of SVF is investigational. "Investigational" means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA). The FDA is allowing the use of this drug for research. The investigators goal is to determine the effectiveness of SVF cell injection to treat small rotator cuff tears without surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin Glue | Active Comparator | Single 4 milliliter (mL) injection of 0.9% normal saline and fibrin glue solution |
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| SVF cells and Fibrin Glue | Experimental | Nucleated adipose-derived cells loaded in a fibrin glue scaffold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tisseel Injectable Product | Drug | Fibrin glue will provide an inert, biocompatible, viscous substance able to remain within the Rotator Cuff (RC) defect rather than injecting SVF cells in saline. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy - MRI-measured healing rate in the rotator cuff tear | Healing rates between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group. | 24 months |
| Primary Safety - Incidence/Rates of adverse events (AEs) involving the affected joint | Both study-related AE assessments and the clinical record will be interrogated to determine if the subjects had any adverse events involving the affected joint. Incidence and rates of AEs between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported measures Western Ontario Rotator Cuff (WORC) Index | WORC score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP. The investigators expect the SVF-treated patients to improve by over 12% on the WORC at the final 2-yr follow-up. | 24 months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Tariq Awan, DO | AdventHealth Orlando | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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Subjects will be randomized 1:1 to SVF Cells & Fibrin Glue or Fibrin Glue alone.
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The provider (PI) and team performing the injection will not care for the subject during follow up.
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| Stromal Vascular Fraction Cells | Biological | Stromal Vascular Fraction cells are autologously harvested, processed and reinjected into the affected shoulder. |
|
| Patient-reported measures Patient Reported Outcomes Measurement Information System (PROMIS) |
PROMIS score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP.expect the SVF-treated patients to improve by 10 points on the PROMIS at the final 2-yr follow-up. |
| 24 months |
| Patient-reported measures Visual Analog Scale (VAS) | Pain VAS score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP. expect the SVF-treated patients to improve by over 12% on the WORC, by 10 points on the PROMIS, and by 20% on the pain VAS by the final 2-yr follow-up. expect the SVF-treated patients to improve by 20% on the pain VAS at the final 2-yr follow-up. | 24 months |